The invention relates to an apparatus for providing topical hemorrhoid therapy either via heat or cooling as desired by the user.
There are devices known which provide for topical therapy, not necessarily for hemorrhoids, such as the patent to Newman, U.S. Pat. No. 2,190,383, which provides a flexible applicator bag with inlet and outlet means, but which requires pressurization by a gas charge in the applicator bag and encompasses the use of electric pumping means and heating means for the therapeutic fluid. Because of the absence of internal support it is not clear that this device would be efficacious as a rectal inserter.
Another prior art device is that disclosed in the Zichlin U.S. Pat. No. 2,345,245 which encompasses a hard-shelled inserter device, constructed of "Lucite" or the like, with inlet and outlet means for supplying hydraulic fluid to heat or cool the device. An electrode heating means is provided centrally of the insertion device which renders this device quite complicated in construction and potentially less safe to use.
Still another prior art device is the topical hypothermia device disclosed in Wolvek et at, U.S. Pat. No. 4,111,209. This method for therapy provides a bladder for insertion into the heart for use in cardio-pulmonary surgery to lower the bood temperature to prevent hemorrhaging. While a bag-like device with fluid entrance and exit apertures is provided with a double lumen, the device is designed to be inserted wholly within an organ, such as a heart or uterus, and inflated to a sustainable position by fluid under pressure. The device is substantially different in construction and the method is different in use from that of applicant.
The final prior art device which is relevant to this apparatus is a product sold under the trademark ZEROID. The ZEROID device provides a sealed inserter in which coolable fluid is disposed. The inserter is refrigerated so as to freeze the fluid which releases its cooling effect to the hemorrhoidal region while thawing. The only way to continue the therapy is to refreeze the unit. No provision is made for warming therapy and there is no way to provide a specific cooling level above freezing for particularly sensitive persons whose rectal region could not stand such cold exposure.